Opioid Epidemic: FDA Drafts Guidance on Developing Depot Buprenorphine Products

Regulatory NewsRegulatory News
| 20 April 2018 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Friday released the first of two draft guidance documents explaining the agency’s current thinking on medication-assisted treatments (MAT), with this one on the drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (i.e., modified-release products for injection or implantation) to help those with opioid use disorder.

A priority for the agency has been encouraging more innovation in the development of MAT. Currently, there are three FDA-approved MAT drugs – methadone, buprenorphine and naltrexone.

“Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications,” said FDA Commissioner Scott Gottlieb. “The FDA will continue to encourage more widespread innovation and development of new and better treatments for opioid addiction as well as tackle the unfortunate stigma that’s sometimes associated with use of these treatments.”

Draft Guidance

The 20-page draft offers details on development programs for depot buprenorphine products, including the types of studies necessary to support approvals and efficacy trials.

This draft guidance also clarifies that some MAT products can be submitted in an application under the 505(b)(2) pathway, which allows the agency to rely on data not developed by an applicant.

“For example, a proposed monthly subcutaneous depot buprenorphine product that does not meet criteria for submission under an ANDA [abbreviated new drug application] may be submitted under a 505(b)(2) NDA [new drug application] with relative bioavailability pharmacokinetic studies, and may not require additional efficacy and/or safety studies in certain instances,” the draft says. “Applications for other depot buprenorphine products with novel features could also be eligible for submission through the 505(b)(2) pathway, but may require efficacy and/or safety trials.”

Passive-compliance formulations, such as sustained-release injectable depots and implants, can provide effective treatment of opioid dependence that may be less subject to misuse, abuse or accidental exposure when compared to self-administered formulations, FDA explains.

In addition to the draft, FDA also recently published a paper with the National Institute on Drug Abuse to describe efforts to overcome some of the barriers to new drug development and the issues with how FDA determines effectiveness.

And earlier this week, FDA hosted a Patient Focused Drug Development meeting to hear patients’ perspectives on opioid use disorder, including the effects on their health and well-being, experience with MAT and other treatments or therapies.

Opioid Dependence: Developing Depot Buprenorphine Products for Treatment Draft Guidance for Industry


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